Randomised, double-blinded, placebo-controlled trial assessing the efficacy of Mi-Gel® in the treatment of women with vulval pain / entry dyspareunia.
TA Pharma Pty Ltd
174 participants
Feb 28, 2025
Interventional
Conditions
Summary
This research study is for women with a diagnosis of vulval pain / entry dyspareunia (pain at the level of the vaginal entry). Entry dyspareunia has a variety of causes and can be linked to pudendal neuralgia, hypoestrogenism or vulvodynia. Vulvodynia is described as vulvar pain of at least 3 months duration, without clear identifiable cause. Pudendal neuralgia, like vulvodynia, is a nerve pain condition diagnosed in the absence of other causes. Amitriptyline is an effective pain medication that is often used orally (in a tablet) for the treatment of nerve pain. However, this is sometimes not well tolerated due to side effects. When applied topically (directly onto the affected area) instead of orally, amitriptyline works locally, on nerves where it is applied, and there is evidence that it is better tolerated. Oestriol is one of the three main oestrogens produced naturally by the body. We have found that many of our patients with entry dyspareunia, pudendal neuralgia and vulvodynia have skin changes suggestive of low oestrogen levels. Treatment with topical oestrogen improves skin health and can reduce pain. This study will assess the effectiveness of a topical gel containing both amitriptyline and oestriol in the treatment of this pain. The study is designed to measure the effect the treatment has on pain as a result of entry dyspareunia; bladder function; sexual function; and whether it causes any adverse effects. The study hypothesis is that the use of Mi-Gel will result in a statistically significant reduction in vulval pain, as measured by the Numeric Rating Scale (NRS) change from baseline at Week 12, compared to placebo.
Eligibility
Inclusion Criteria14
- Female sex recorded at birth.
- Aged 30 years or over at consent.
- Vulval pain with sexual activity/entry dyspareunia diagnosis of at least 3 months at time of consent.
- Have been pregnant and delivered one or more babies.
- Willing to apply cream/gel to the vulva twice daily for the 12 week treatment period.
- Experiencing either:
- a: Grade 2 or 3 Entry Dyspareunia based on the Marinoff Entry Dyspareunia Classification Scale OR
- b: Grade 1 Entry Dyspareunia based on the Marinoff Entry Dyspareunia Classification Scale, Experiencing pain at the level of the vulva
- AND
- Experiencing vulval pain with sexual activity or attempted sexual activity (e.g. finger, instrument or penis) into the vaginal entry (NRS at screening of greater than or equal to 4 on average in the past 7 days)
- Normal genital physical examination by a registered health practitioner in the past 90 days.
- Willing to treat mild thrush, if present at screening and any occurrence during the treatment period with oral medication (fluconazole).
- Willing and able to use a smartphone for regular study data collection (questionnaires) for the duration of the study.
- Capable of providing consent (understand English and have the cognitive ability to provide consent).
Exclusion Criteria16
- Known history of ongoing serious mental health issue.
- Known allergy or contraindication to amitriptyline or estriol.
- Known history of breast cancer less than 10 years before consent.
- Known history of genital cancer less than 10 years before consent.
- Not sexually active (self or with partner).
- Currently using or has used in the last 6 weeks prior to treatment, amitriptyline, nortriptyline or estriol in any way (oral or topical) and not willing to cease before baseline data collection.
- History of hyperemesis gravidarum.
- Prior diagnosis of provoked vulvodynia (before pregnancy and/or before the age of 30)
- Uncontrolled or excessive menstrual bleeding that is not able to be controlled.
- Pudendal Nerve Block procedure within the last 90 days before baseline or planning on having a Pudendal Nerve Block procedure during the course of the trial.
- Pregnant (as determined by a urine pregnancy test as applicable), breastfeeding or unwilling to use methods to avoid potential pregnancy for the study duration and for 30 days after the last treatment application.
- Current peri-vaginal infections or vulvovaginal disorders, including current moderate-severe untreated candidiasis, such as active desquamative inflammatory vaginitis/psoriasis/lichen sclerosis, or other similar conditions in the opinion of the investigator.
- Uncontrolled health conditions that could affect the lubrication or contribute to vulval pain/entry dyspareunia, such as Sjogren’s Syndrome, scleroderma or other similar conditions in the opinion of the investigator.
- Prior participation in a Mi-Gel® clinical trial.
- Current participation in a clinical trial, or participation in a clinical trial within 12 weeks prior to consent.
- The investigator believes the candidate would not make a good clinical trial participant.
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Interventions
Arm 1 - Mi-Gel, contains amitriptyline 5 mg/g (0.5% w/w) and estriol 0.3 mg/g (0.03% w/w)] in a topical gel formulation. Dose of 0.5mL applied twice daily, topically, to vulva for 12 weeks. The product is shipped directly to patient from a GMP manufacturing facility and is weighed prior to sending. A return package will enable the patient to return the tubes back to the depot after 12 weeks of use for weighing and compliance calculation.
Locations(1)
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ACTRN12624001210561